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The United States is one of the world's largest markets for chemicals, but entering and remaining in the US market requires companies to understand a complex regulatory framework.

At the center of US industrial chemical regulation is the Toxic Substances Control Act (TSCA).

The US Environmental Protection Agency, or EPA for short, is in charge of something called TSCA. This gives the EPA the power to make companies report certain information, keep records, and do testing on chemicals. They can also look at new chemicals before they're used, check out chemicals that are already being used, and stop companies from using chemicals that are too risky. The goal is to protect people and the environment from chemicals that could hurt them.

For manufacturers, importers, processors, and exporters supplying chemicals to the United States, the challenge is not simply understanding what TSCA is.

The more important questions are:

Is my substance listed on the TSCA Inventory?

Can I import it into the United States?

Does a notification or reporting obligation apply?

Is the substance subject to restrictions or a Significant New Use Rule?

Have any deadlines or regulatory requirements recently changed?

The GPC Gateway is a tool that helps people who work with regulations figure out what they need to do. It puts together information about rules in the US, details about specific chemicals, and important dates, all in one place. This makes it easier for them to get the answers they need and stay on top of things.

What Is TSCA?

The Toxic Substances Control Act (TSCA) was enacted in 1976 and significantly amended in 2016 through the Frank R. Lautenberg Chemical Safety for the 21st Century Act.

TSCA provides EPA with authority over many chemical substances manufactured, processed, distributed, used, or imported into the United States.

EPA uses TSCA to:

• Maintain the TSCA Chemical Substance Inventory

• Review new chemical substances before they enter commerce

• Require testing and information from companies

• Collect information on chemicals in commerce

• Evaluate risks associated with existing chemicals

• Establish restrictions where unreasonable risks are identified

• Regulate significant new uses of certain chemicals

• Establish recordkeeping and reporting obligations

• Address certain chemical import and export requirements

EPA describes the TSCA Inventory as central to the regulation of most industrial chemicals in the United States. The publicly available Inventory currently contains more than 86,000 chemical substances, with substances categorized according to their regulatory status.

Some products are controlled by laws other than TSCA. These include pesticides, food and food additives, medicines, cosmetics, tobacco products, certain nuclear materials, and munitions. They have their own set of rules to follow.

Why Is TSCA Compliance Challenging for Companies?

TSCA is not a single registration requirement that companies complete once.

Different obligations may apply depending on:

• The identity of the chemical

• Whether it is already on the TSCA Inventory

• Whether it is considered a new or existing chemical

• The company's role in the supply chain

• Manufacturing or import activities

• Intended uses

• Production volumes

• Exposure conditions

• Applicable exemptions

• Existing restrictions

• Significant New Use Rules

• Reporting requirements

• EPA risk-management actions

This means companies need to understand both their substance-specific obligations and ongoing regulatory developments.

Sometimes, a chemical that was okay to use for something in the past might later have more rules to follow, like extra safety measures, reporting what you're doing with it, controlling how it's used at work, or even limits on using it at all. This can happen as we learn more about the chemical and its potential risks.

That makes regulatory monitoring an ongoing requirement rather than a one-time market-entry activity.

How GPC Gateway Helps Manage TSCA Compliance

The GPC Gateway has a special section for the US regulatory system, where you can find information about the rules and laws that govern chemicals in the United States, including the Toxic Substances Control Act, or TSCA for short.

The platform puts all the important information in one place, including rules, lists of chemicals, news, and tools to help companies follow the rules. It also gives them access to special reports and resources they can download. The part of the platform for the US has extra features, like a search tool that helps companies find the rules that apply to specific chemicals. This makes it easier for them to know what they need to do to comply with the regulations.

Here are some of the main ways GPC Gateway can support TSCA compliance activities.

1. Understanding Whether a Chemical Falls Under TSCA

One of the first things a company should figure out before sending a chemical to the United States is:

Does TSCA apply to this substance and its intended use?

TSCA covers many industrial chemicals, but certain categories are excluded because they are primarily regulated under other federal statutes.

Determining applicability is therefore an important first step.

GPC Gateway's US regulatory information helps users understand the scope of TSCA and the types of obligations that can arise for manufacturers and importers.

This gives companies a basic outline of what to expect from regulators before they dive into a more in-depth evaluation of specific substances.

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2. Checking TSCA Inventory Status

The TSCA Chemical Substance Inventory is one of the most important starting points for chemical compliance in the United States.

EPA maintains the Inventory under TSCA Section 8(b).

When it comes to regulations, chemicals that are already on the Inventory list are usually thought of as existing chemicals. On the other hand, chemicals that aren't on this list are generally considered new chemical substances. This distinction is important because it affects how these chemicals are treated and regulated.

This distinction can have major compliance consequences.

When a company wants to make or bring in a substance that's not already listed, they might have to send a special notice to the EPA first. This notice is called a Premanufacture Notice, or PMN for short. The company needs to do this before they start making or importing the substance for business purposes, unless it's exempt. The EPA uses this notice to get more information about the substance and make sure it's safe for people and the environment.

EPA generally requires a PMN at least 90 days before manufacturing or importing a new chemical for a non-exempt commercial purpose.

For regulatory teams, the logical first assessment is therefore:

Substance identity → TSCA Inventory status → applicable obligations

GPC Gateway helps users navigate US regulatory information from this substance-oriented perspective.

3. Identifying New Chemical Obligations

Being unable to find a substance on the TSCA Inventory should not simply be treated as a database issue.

It could mean the substance is seen as new according to the Toxic Substances Control Act rules.

TSCA Section 5 establishes requirements for the review of new chemicals before they enter US commerce.

Depending on what we're dealing with and the situation, there are different ways things can go, including various submissions or pathways that might be relevant.

• Premanufacture Notices

• Significant New Use Notices

• Microbial Commercial Activity Notices

• Certain exemption applications

EPA reviews new chemicals to determine whether they may present an unreasonable risk or whether additional regulatory measures are necessary before commercialization.

As of July 1, 2026, EPA reported hundreds of PMN, SNUN, and MCAN cases in different stages of the new chemicals review process, illustrating the continuing importance of Section 5 for companies bringing chemicals to the US market.

Understanding whether Section 5 requirements apply should therefore form part of any US market-entry assessment.

4. Monitoring Significant New Use Rules

A substance being listed on the TSCA Inventory does not necessarily mean that every new use is automatically permitted without additional regulatory action.

EPA can issue a Significant New Use Rule (SNUR) under TSCA Section 5 when it determines that a particular new use of a chemical may result in different or increased exposure.

A company intending to manufacture, import, or process a chemical for a use designated as significant may need to notify EPA before commencing that activity.

For manufacturers and importers, this means compliance assessment should consider both:

Is the chemical on the Inventory?

and

Is the intended use subject to additional TSCA requirements?

The GPC Gateway provides regulatory information and regular US updates to help teams responsible for regulatory compliance stay informed about changes that might impact specific chemicals or their uses.

5. Understanding TSCA Import Requirements

International manufacturers selling chemicals into the United States need to pay particular attention to TSCA import requirements.

Under TSCA Section 13 and associated customs requirements, importers may need to certify whether imported chemical substances or mixtures comply with TSCA.

GPC Gateway's TSCA regulatory summary highlights the positive and negative certification framework applicable to chemical imports.

Depending on the product and circumstances, importers may certify that:

The chemical shipment must follow the rules of the Toxic Substances Control Act and meet all the necessary standards.

The chemical is not subject to TSCA.

Import certification therefore needs to be considered before chemicals enter the US market.

For companies making products outside the US, it's really important to know what's required because when their products cross the US border, the importer or their representative might be held legally responsible.

6. Following TSCA Reporting Requirements

TSCA gives EPA substantial authority to collect information from manufacturers, importers, and processors.

One important example is Chemical Data Reporting (CDR) under TSCA Section 8.

The CDR rule requires certain manufacturers, including importers, to provide EPA with information concerning chemicals manufactured or imported into the United States.

EPA uses CDR information to understand:

• Chemicals in commerce

• Production volumes

• Uses

• Processing activities

• Potential exposure

The information supports chemical prioritization, risk assessment, evaluation, and risk-management activities.

TSCA Section 8 can also involve other reporting and recordkeeping obligations.

Because reporting requirements and deadlines can change, companies should monitor regulatory developments rather than relying solely on previous reporting cycles.

7. Tracking Risk Evaluation and Risk Management

The 2016 amendments to TSCA significantly strengthened EPA's responsibilities for reviewing existing chemicals.

EPA's process for existing chemicals broadly involves:

Prioritization → Risk Evaluation → Risk Management

If EPA determines through a risk evaluation that an existing chemical presents an unreasonable risk to human health or the environment, the agency must move into risk management.

Potential regulatory actions can include:

• Restrictions on particular uses

• Workplace protection requirements

• Exposure controls

• Labelling requirements

• Recordkeeping

• Notifications

• Limitations on manufacture or processing

• Restrictions on distribution

• Prohibitions of certain uses

EPA continues to conduct risk evaluations and develop risk-management measures for chemicals already present in US commerce.

This is important for businesses because being on the TSCA Inventory does not guarantee that regulatory conditions will remain unchanged.

Businesses should be aware of when the EPA starts assessing a substance in their collection and if proposed or final risk-management measures could impact their daily operations, so they can plan ahead and make necessary adjustments to stay compliant. This is important because it can affect how they run their business and make decisions about the substances they use.

Regulatory Monitoring: An Essential Part of TSCA Compliance

TSCA is continually evolving through:

• EPA rulemaking

• New chemical determinations

• SNURs

• Risk evaluations

• Risk-management rules

• Reporting requirements

• Deadline extensions

• Guidance documents

• Inventory updates

For example, GPC Gateway's US regulatory feed reported EPA's May 22, 2026 final rule extending a TSCA Section 8(d) health and safety data reporting deadline by one year.

This shows that companies can't just depend on an assessment of a chemical that was done when it was first introduced under the TSCA. They need to keep evaluating the chemical's safety over time.

Regulatory intelligence needs to remain active throughout the product lifecycle.

Bringing TSCA Information Together in One Place

Regulatory teams often obtain TSCA information from multiple sources.

They may need to separately check:

• EPA regulations

• TSCA Inventory information

• Federal Register notices

• New chemical actions

• Chemical-specific restrictions

• Risk evaluations

• Regulatory deadlines

• Reporting obligations

• Guidance documents

For companies managing multiple substances, following each source individually can become time-consuming.

GPC Gateway is designed to make regulatory intelligence easier to navigate by bringing relevant information together within a structured portal.

For the USA, users can access areas covering:

• Regulations

• Chemical inventory information

• GHS status

• Regulatory briefings

• News

• Compliance resources

• FAQs

• Events

• Deadlines

• Downloadable content

• Chemical-specific searches

The GPC Gateway also shares important updates on rules and laws that affect businesses, explaining what these changes might mean for companies in a way that's easy to understand and use.

Using Chemical-Specific Searches for Better Compliance Decisions

General regulatory information is valuable, but regulatory teams ultimately need answers relating to their own substances.

Questions commonly include:

• Is my substance covered?

• What regulatory action may be required?

• Does an inventory requirement apply?

• Are there restrictions associated with the substance?

• Has the regulation recently changed?

You can look up rules for specific chemicals on GPC Gateway's USA Compliance Advisor. This includes searching by CAS number to find out what regulations apply to certain chemicals.

This approach shifts the focus of regulatory research away from general laws and towards evaluating compliance for specific substances, making it more targeted and effective.

For companies managing large chemical portfolios, this approach can help regulatory professionals prioritize which substances require closer attention.

A Practical TSCA Compliance Checklist

When evaluating a chemical for the US market, regulatory teams should consider the following questions.

Substance Identification

Do you have the correct chemical name, CAS number, composition, and relevant substance identifiers?

TSCA Applicability

Does the intended substance and use fall within the scope of TSCA?

Inventory Status

Is the substance listed on the TSCA Chemical Substance Inventory?

New Chemical Requirements

If the substance is not listed, does a PMN or another Section 5 requirement apply?

Significant New Uses

Is the substance or proposed activity affected by a SNUR?

Import Requirements

Have applicable TSCA import certification obligations been evaluated?

Reporting

Do CDR, Section 8, or other reporting requirements apply?

Restrictions

Is there a current rule or restriction in place for managing the risks associated with this chemical, or are there any existing regulations that apply to it?

Regulatory Developments

Is EPA currently evaluating or proposing additional requirements for the substance?

Deadlines

Are there upcoming reporting, notification, or compliance deadlines that could affect your business?

If you're unsure about any of these questions, you might need to do some extra checking to make sure everything is okay with the rules and regulations.

From TSCA Information to Regulatory Intelligence

The biggest challenge for many companies isn't actually finding the text of the Toxic Substances Control Act, but rather understanding and navigating its complex requirements and regulations.

The challenge is determining:

What does TSCA mean for our chemical and our business?

Effective regulatory intelligence connects legislation to practical questions such as:

• Which chemicals in our portfolio are affected?

• What action should we take?

• Who is responsible?

• When is action required?

• What happens if EPA changes the regulatory status?

• Could a new restriction affect our US supply chain?

GPC Gateway helps bridge the gap between regulatory information and practical compliance awareness by combining chemical-specific resources with regulatory briefings, deadlines, updates, and country-level information.

Conclusion

TSCA compliance is a continuous process.

For companies manufacturing, importing, processing, or supplying chemicals to the United States, compliance can involve much more than simply checking whether a substance appears on the TSCA Inventory.

Companies may need to consider:

• Inventory status.

• New chemical notification.

• Significant new uses.

• Import certification.

• Reporting requirements.

• Risk evaluations.

• Restrictions.

• Regulatory deadlines.

• Ongoing EPA developments.

As EPA continues to evaluate chemicals and update regulatory requirements, staying informed is essential for maintaining market access and reducing compliance risk.

GPC Gateway helps regulatory professionals navigate this complexity by providing structured access to US regulatory information, chemical-specific searches, regulatory briefings, news, deadlines, and supporting compliance resources.

Stay Informed About TSCA Requirements in the United States

Explore GPC Gateway to better understand US chemical regulatory requirements and monitor developments that could affect your substances and business.

Registration is free.

Create Your Free GPC Gateway Account →

GPC Gateway provides regulatory intelligence to support compliance assessment. Companies should verify legally binding requirements and substance-specific determinations against applicable EPA regulations and official sources where necessary.